Pharmaceutical Development Group (PDG) is a subsidiary of Biotech Research Group Corporation.
NADA Q reported on December 19, 2016 that “Mylan N.V. announced the launch of the first generic version of its life-saving allergy treatment, EpiPen® auto-injector, at more than 50% discount on the branded product’s price. The generic EpiPen® will have a list price of $300 for a pack of two and will reach pharmacies beginning…
Last month, we reported that New Guidance on Medical Device Reporting Supersedes Guidance in Use Since 1997. This guidance document is intended to assist medical device manufacturers meet applicable reporting and recordkeeping requirements for certain device-related adverse events and malfunctions. There have been numerous changes to the medical device reporting requirements since the FD&C Act…
According to the Background, “This guidance outlines the recommended format and content for a sponsor to submit physiologically based pharmacokinetic (PBPK) analyses to the FDA to support applications including investigational new drug (INDs) applications, new drug applications (NDAs), biologics license applications (BLAs), or abbreviated new drug applications (ANDAs). To enable efficient and consistent review, the…
According to FDA Commissioner Robert M. Califf, M.D. and Nina L. Hunter, Ph.D., FDA’s Associate Director for Science Policy in the Office of Medical Products and Tobacco, “About a year ago, we shared with you our Combination Product Review, Intercenter Consult Process Study Report, which was developed by FDA’s Office of Planning. The report’s findings were…
The Washington Post recently reported that “The bill provides for $4.8 billion in new funding for the National Institutes of Health; of that, $1.8 billion is reserved for the “cancer moonshot” launched by Vice President Biden to accelerate research in that field. Another $1.6 billion is earmarked for brain diseases including Alzheimer’s. Also included are…
FiercePharma recently reported “Trump wants to battle high drug prices? Let’s work together, hike-fighting senator says.” In the story, Sen. Amy Klobuchar (D-Minnesota), has a message for President-elect Donald Trump: “Let’s bring drug prices down together… In a new op-ed for USA Today, Sen. Klobuchar outlined several tactics that, if implemented, would reduce prices in the U.S., she…
While this FDA web upgrade is not breaking news (it first appeared in July 2016), it is worth knowing about. Previously hard to find documents, many requiring purchase from outside vendors or long FOIA wait times, may now be found instantaneously and free of charge. Included (among others) are EIRs, 483s, 483 responses, etc. To…
Recently, GoodRx, Inc. reported that “Several times a year, GoodRx creates a list of the most-dispensed prescriptions in the U.S. To form our list, we look at a sample of claims as reported by pharmacies across the country. We combine prescriptions for brands and generics; we also display the GoodRx Fair Price for the most…
On November 8, 2016, FDA issued Medical Device Reporting for Manufacturers Guidance for Industry and Food and Drug Administration Staff noting that the draft was issued on July 9, 2013 and that the new guidance supersedes Medical Device Reporting for Manufacturers dated March 1997. According to the Notice of Availability (81 FR 78603) “The draft…
As one of the partners in the White House “Brain Research through Advancing Innovative Neurotechnologies Initiative” (BRAIN), FDA is “working to enhance the transparency and predictability of the regulatory process for developers and innovators of neurological medical devices.” Recently, FDA announced a new website “intended to assist neurological device developers, sponsors and innovators with navigating…